A worker at Vedanta's new manufacturing site (via Vedanta)

Vedan­ta opens man­u­fac­tur­ing fa­cil­i­ty to pro­duce lead can­di­date as it heads for PhI­II

The mi­cro­bio­me start­up Vedan­ta, while still forg­ing ahead with the Phase III process for its Clostrid­ioides dif­fi­cile in­fec­tion can­di­date, has com­plet­ed a man­u­fac­tur­ing fa­cil­i­ty to pro­duce the drug.

Vedan­ta’s new 7,000-square-foot fa­cil­i­ties in Cam­bridge, MA, are de­signed to man­u­fac­ture clin­i­cal and com­mer­cial sup­plies for its port­fo­lio, in­clud­ing their oral c. dif­fi­cile can­di­date VE303.

The fa­cil­i­ty is an ex­ten­sion of the com­pa­ny’s ex­ist­ing man­u­fac­tur­ing ca­pa­bil­i­ties and can pro­duce mul­ti­ple drug can­di­dates, ac­cord­ing to Vedan­ta. It al­so has CGMP ca­pa­bil­i­ties to han­dle every­thing from clin­i­cal de­vel­op­ment to com­mer­cial launch. Man­u­fac­tur­ing is ex­pect­ed to kick off in Q4 of this year.

The cost of the fa­cil­i­ty and em­ploy­ment de­tails were not dis­closed to End­points News, though Vedan­ta did con­firm in an email that gov­ern­ment funds were giv­en to the com­pa­ny. The com­pa­ny is a fund­ed con­trac­tor of BAR­DA and sup­port went to Vedan­ta’s lead pro­gram and se­lect as­pects of the fa­cil­i­ty de­sign and com­mis­sion­ing, Vedan­ta said.

In Oc­to­ber of 2021, pos­i­tive Phase II re­sults trig­gered a $23.8 mil­lion op­tion from BAR­DA. The funds have been used to sup­port the can­di­date in sev­er­al ca­pac­i­ties in­clud­ing man­u­fac­tur­ing.

“This fa­cil­i­ty, com­bined with the ex­per­tise and tal­ent of our team, is de­signed to man­u­fac­ture our mi­cro­bio­me prod­uct can­di­dates as stan­dard­ized com­po­si­tions with con­sis­tent qual­i­ty at­trib­ut­es at a large scale,” Vedan­ta CEO Bernat Olle said in a state­ment.

The com­pa­ny’s first pro­duc­tion runs at the new fa­cil­i­ty will sup­ply a planned Phase III study of VE303, but the time­line of that tri­al has not been dis­closed to End­points.

Vedan­ta has been on the charge as of late with its lead can­di­date. In 2021, it wrapped up a $68 mil­lion Se­ries D raise, which in­clud­ed a $25 mil­lion eq­ui­ty in­vest­ment from Pfiz­er. The com­pa­ny net­ted a $45.5 mil­lion C round in 2019.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.